Holistic breast patch

ABSTRACT

The Holistic Breast Patch is the first known, non pharmaceutical, effective device available which inhibits prolactin production safely and aids the relief of discomfort from breast engorgement pain by drying breast milk after pregnancy. It will also aid in the treatment of prolactin dependent diseases and conditions that respond to prolactin inhibition. The availability of this device greatly eliminates the serious risks of health complications and fatalities that have been documented by the use of prescription drugs, hormones and pharmaceuticals lacking FDA approval for this use. The Holistic Breast Patch works transdermally and is comprised of a unique, natural and organic carbonyl disc housed within cotton gauze and nonstick adhesive Telfa forming an approximately 1½ inch by ¾ inch adhesive] patch. The Federal Drug Administration has determined it to be a non-significant risk device (21 CFR 812).

CROSS-REFERENCE TO RELATED APPLICATIONS

Substitute for application Ser. No. 12/804,315

Filing Date: Jul. 19, 2010

Previous filing: WO/1998/031406 Holistic Breast Patch,

International Application Number: PCT/US1997/002461

Filing Date: 14 Feb. 1997

Publication Date: 23 Jul. 1998

U.S. patent application Ser. No. 09/552,159, abandoned 19 Mar. 2002

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable

REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTINGCOMPACT DISC APPENDIX

Not applicable

BACKGROUND OF THE INVENTION

This invention endeavors to provide a safe, comfortable, easy to usedevice to relieve the pain and discomfort associated with postpartumbreast milk engorgement, to expedite the suppression of lactation forwomen who choose not to breast-feed, and to aid in the treatment ofprolactin dependent and related diseases and disorders. This isaccomplished by inhibiting the production of prolactin which suppresseslactation.

After pregnancy, a woman naturally produces breast milk for a period oftime. The length of time for postpartum milk production varies dependingupon whether or not the mother breast-feeds and how long shebreast-feeds. For breast-feeding mothers, milk production can continueup to twenty four months or longer. For non-breast-feeding women, theduration is impacted by whether or not and for how long her breasts werepumped or stimulated to produce milk. Women who choose not tobreast-feed experience discomfort and pain due to breast engorgement.Relief is sought through breast pumping and stimulation which prolongsproduction and delays suppression of milk production, ice packs, breastbinding which can cause mastitis and various other means that haveproven to be dangerous or otherwise unsuccessful.

According to Treatment for Lactation Suppression, Little Progress in OneHundred Years (Am J Obstet Gynecol 1998; 179:1485-90) “Engorgement andbreast pain may encompass most of the first postpartum week. Up to onethird of women who do not breast-feed and who use a brassiere or binder,ice packs, or analgesics may experience severe breast pain. Specificstudies of nonpharmacologic methods of lactation suppression werelimited and inconclusive. Available data suggest that many women usingcurrently recommended strategies for treatment of symptoms maynevertheless experience engorgement or pain for most of the firstpostpartum week.

There is no Federal Drug Administration (FDA) approved treatment for therelief of breast milk engorgement pain. Prescription drugs such as,parlodel (bromocriptine mesylate), a previously FDA approved lactationsuppressant and estrogens and androgens (gonadotrophic hormones) havebeen prescribed and are possibly still being used as a prolactininhibitor to suppress milk production for breast engorgement relief andto treat prolactin related disease and conditions.

Parlodel inhibits the secretion of the hormone prolactin from thepituitary gland. It also mimics the action of dopamine, a chemicallacking in the brain of a person with Parkinson's disease. Palodel andestrogens and androgens have been used to treat a variety of medicalconditions, including lactation suppression, Infertility, menstrualproblems such as galactorrhoea and prolactin dependent amenorrhea, withor without excessive production of milk. However, it has been welldocumented in the literature that these drugs and hormones have producedadverse effects including death. Some of the documentation is in theliterature that follows.

To address problems involved in the prior art, reference is made to theDec. 1, 1989 FDA Consumer which states “FDA has asked that themanufacturer of the drug Parlodel (bromocriptine) stop labeling the drugfor use in drying up milk production and preventing breast engorgementin mothers who don't breast-feed. (Parlodel is approved for treatment ofParkinson's disease.)

In a related move, FDA requested that the manufacturers of productscontaining estrogen and androgens stop labeling these gonadotrophichormones as lactation suppressants. FDA's Fertility and Maternal HealthDrugs Advisory Committee suggested the changes, in part, because thesedrugs, which can have serious side effects, benefit only 10 percent ofthe women who use them to suppress lactation. Also, the drugs'effectiveness is also diminished because of the high occurrence ofrebound. Breasts become engorged again after the woman stops taking thedrugs.”

The Health facts newspaper Sep. 1, 1994, edition states “Parlodel, adrug widely used to suppress breast milk following childbirth hasfinally been withdrawn by its manufacturer Sandoz, five years after itwas found to be dangerous and ineffective. The action came on the heelsof a national TV investigative report and a lawsuit against the FDA bythe Public Citizen's Health Research Group and the National Women'sHealth Network.

The two consumer groups took legal action against the FDA because theagency failed to ban the drug as a lactation suppressant after receivingreports of its dangers. Since 1980, according to Public Citizen, the FDAhad received 531 adverse reactions reports, including 32 deaths, 14 fromstroke and five heart attacks. Among the nonfatal reactions, there were36 strokes, 14 heart attacks, and 98 seizures; many of these casesinvolve permanent disability. Underreporting is a very real possibilityas the FDA's post market surveillance system is notoriously weak (RxNews August 1994).”

In the Oct. 1, 1994, issue of Trial Magazine, it is stated “Under abarrage of consumer criticism and a lawsuit, the manufacturer ofParlodel said it will no longer market the drug as a lactationsuppressant. The drug has been blamed for the deaths of at least 32 newmothers and for medical problems in hundreds of women since it receivedU.S. Food and Drug Administration (FDA) approval in 1980.”

In the United States, the sharp restriction in the use ofpharmaceuticals to aid the suppression of breast milk and the discomfortand pain from engorgement, has resulted in essentially no recognizedmechanism for lactation suppression and relieving the discomfort ofbreast milk engorgement. The formerly used pharmaceutical items are nolonger available as a prescription for lactation suppression. They arehowever, offered online through Canadian and United Kingdom Pharmacieswithout a prescription. This availability again exposes mothers to theserious documented risks. Accordingly, there is an urgent need for analternative method which will relieve the discomfort of breastengorgement pain and expedite the suppression of breast milk productionin a safe, convenient, efficient, and legal manner.

“There is increasing evidence that prolactin (PRL), a hormone/cytokine,plays a role in breast, prostate, and colorectal cancers via localproduction or accumulation.” (Cancer Res 2009; 69(12):5226-33) Breastcancer is the most common cancer among American women, except for skincancers. The chance of developing invasive breast cancer at some time ina woman's life is a little less than 1 in 8 (12%). Breast cancer is thesecond leading cause of cancer death in women, exceeded only by kingcancer.” (American Cancer Society, Dec. 9, 2011) Other than skin cancerprostate cancer is the most common cancer in American men. About 1 manin 6 will be diagnosed with prostate cancer during his lifetime.Prostate cancer is the second leading cause of cancer death in Americanmen, behind only lung cancer.” (American Cancer Society Oct. 12, 2011)

Current treatment of prolactin dependent and related diseases andconditions involves the use of neutralizing prolactin receptorantibodies and antigen binding fragments, through pharmaceutical agentsincluding dopamine antagonists and monoclonal drugs. Thesepharmaceutical drugs effect the amino acid sequence of the extracellulardomain of the prolactin receptor and the nucleic acid sequence wherebythe pharmaceutical composition antagonizes the prolactin receptormediated signaling. (US Fed News Service, Including US State News, Jun.16, 2011, WIPO Assigns Patent To Bayer Schering Pharma for “NeutralizingProlactin Receptor Antibodies and their therapeutic use.” abstract)Recent studies indicate “Several PRL receptor (PRLR) antagonists havebeen identified in the past decades, but their in vivo growth inhibitorypotency was restricted by low receptor affinity, rendering thempharmacologically unattractive for clinical treatment.” PEDS OxfordJournals; Life Sciences & Medicine; Volume 24, Issue 11)

BRIEF SUMMARY OF THE INVENTION

Postpartum milk suppression will readily occur without intervention.This process, however can be lengthy, tedious, and is usually painfulwithout the aid of breast pumps and medication to relieve breastengorgement pain.

This very surprising discovery, a “Holistic (Carbonyl Group) BreastPatch”, referred to as the “Patch”, when worn by postpartum women in aprescribed regimen will significantly reduce the time for lactationsuppression to occur. When lactation is suppressed, the discomfort ofpain associated with breast milk engorgement is relieved and the supportof prolactin dependent and related diseases and disorders is interruptedby inhibiting prolactin production.

The approximately 1½ inch by ¾ inch breast patch is worn by postpartumwomen, generally in the form of a Telfa pad which the mother applies toher chest. The FDA approved Telfa pad consisting of inactive ingredientsis the exterior housing for the “Carbonyl Group” disc containing theactive ingredients.

It is easily applied by the mother between her breasts. This uniquepatch can be put on and removed easily without pain due to Telfa'snonstick adhesive properties. In the rare event of adhesive sensitivity,the Patch can be applied with latex free microspore cotton tape.

The scientific method of the “Holistic Breast Patch” is called“transdermal” because the patch is applied to the skin for the “CarbonylGroup” elements of the Patch to cause lactation suppression a muchshorter length of time than without the aid of the Patch.

The Patch is highly effective in that it successfully suppressespostpartum milk production in three to eight days by comparison to sixto eight weeks or longer without its use.

The Patch conveniently allows postpartum mothers who choose not tobreast-feed the opportunity to recover from childbirth, return toemployment more quickly, protect the newborn from HIV transmission froman HIV positive mother or ease the grief for the mother who suffers theloss of her newborn.

Furthermore, the Holistic Breast Patch is safe in that it has no knownside effects. Therefore, no warnings or precautions are required. Whenmarketed, it will eliminate all of the dangerous, reported fatal adverseeffects of previously used methods to quickly produce lactationsuppression for relief of pain associated with breast milk engorgement.It will also provide a safe and effective method for treatment ofdiseases and conditions that require the inhibition of prolactinproduction. The interior disc of this product consists of all naturalfibers and it is labeled by the Food & Drug Administration (FDA) as adevice and not a drug. The FDA has determined that the Patch meets itsdefinition of a nonsignificant risk device (21 CFR 812).

Many other advantages and other purposes will be made more fullyapparent from a consideration of the forms in which this invention maybe embodied. These forms are illustrated in the following detaileddescription of the invention and in the accompanying drawings. However,this detailed description and the drawings are set forth only for thepurpose of illustrating the general principles of this invention and arenot limited to this illustration only.

OBJECTS OF THE INVENTION

The primary objective of this invention is to provide a safe device tosignificantly reduce the time to achieve lactation suppression, thusexpediting the relief of discomfort of breast engorgement pain in theform of a breast patch which is applied between a woman's breasts.

It is a further object of the present invention to provide a method ofrelieving the discomfort of breast engorgement pain and the drying ofbreast milk without the administration drugs.

It is an additional object of the present invention to provide a deviceof the type stated which is highly efficient, and easy to use.

It is another object of the present invention to provide other benefitsto be determined through consumer testing and/or clinical trial,including but not limited to. treatment of prolactin dependent andrelated diseases.

Consequently, this invention resides in the novel features form,construction, arrangement and combination of part presently describedand pointed out in the claims.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWING

Having thus described the invention in general terms, reference will nowbe made to the accompanying drawings in which:

FIG. 1 is an exploded, perspective view of the Holistic Breast Patch 28:the Telfa pad 30 which is gauze lined on the interior side andnon-adherent perforated film bonded 24 on the exterior side; gauze 22;the “Carbonyl Group” disc 10 and the Telfa pad 30 embodying the presentinvention.

FIG. 2 is a bottom plan view of the disc 10 illustrating the grooves 16.

FIG. 3 is a vertical sectional view of the grooves 16 also designatingthe inner and outer core 18 and 20 through the interior of the “CarbonylGroup” disc 10 taken along line 3-3 of FIG. 2.

FIG. 4 is an elevational view of the disc 10 facing side 12 or 14 withthe top facing up.

FIG. 5 is a perspective view of the disc 10 with the bottom facing up.

FIG. 6 is a bottom plan view of the Holistic Breast Patch 28 with theleft half of the Telfa pad and gauze removed.

FIG. 7 is a top plan view of the Holistic Breast Patch 28 with the righthalf of the Telfa pad and gauze removed.

DETAILED DESCRIPTION OF THE INVENTION

Explaining now the process of making and using this unique invention,reference characters to the drawings which illustrate a preferredembodiment of the invention will also be made in order to give adescription in more detail.

The designated lactation suppression and engorgement pain relief device,the Holistic Breast Patch is worn by postpartum women, generally in theform of a sterile Telfa pad consisting of inactive ingredients:poly(ethylene terephthalate), a thin plastic film lined with a thinlayer of cotton gauze 22. As shown in FIG. 1, this Telfa pad 30 is theexterior housing for the disc 10 which houses the active ingredients:(“Formula” R—Co—R) nickel, manganese, phosphorus, silicon, sulfur, andcarbon) in the form of an interior disc. This formula is called“Carbonyl Group”.

The preferred embodiment is constructed initially as a thin flexible,flat disc 10. This Carbonyl Group” disc 10 is about .75 inch square, hasa top flat surface 17, a bottom grooved surface FIG. 2, and is providedwith 4 very thin sides 12, 13, 14 and 15, FIG. 1, FIG. 2, FIG. 3 . Thethickness of the sides is described in paragraphs 43 and 44.

The inner core of the disc 10 is preferably constructed by forming apiece of high carbon content metal into the shape of a flat disc andthis forming may be by stamping the same from a sheet of such metal.

The inner core 18 should preferably have a thickness of about 49.7 mils,although this can range from about 49.7 mils to about 49.9 mils. Theessentially pure nickel outer layer should have a thickness of about 0.3mils, although the thickness of the outer layer may range from about 0.1mils to about 1.0 mils.

The entire disc is preferred to have an overall thickness of about 50mils, that is, from the top 17 to the bottom 19 FIG. 5. This thicknessis preferred since the disc will then have the necessary structuralintegrity, although it will not be unduly heavy. However, it should beunderstood that the thickness of the disc could vary, depending upon thedesired thickness of the inner core and of the outer layer, ashereinafter described.

The metal which is employed as the inner core 18 contains asubstantially high carbon content, as aforesaid, This carbon contentcould be 0.7% by weight to about 1.5% by weight. In a more preferablerange, the amount of carbon would range from about 0.6% to about 0.9%referred to as high carbon steel. The remaining content of the innercore would be formed of basic metal elements which would include someminor amounts of manganese, chromium, and possibly a minor amount ofnickel. The minor amounts of these other components, such as manganese,chromium, and possibly even nickel, would be less than about 1.0%.

Extending between the sides 12 and 14, and parallel to the sides 13 and15 of the disc 10 FIG. 2 are a plurality of elongated grooves oropenings. These grooves 16 constitute openings on the rear face of thedisc 10 per 19, FIG. 2. They serve as air holes and also as relief forthe disc to bend to conform to the different chest curvatures of theuser, but do not extend in depth through the front surface of the disc10 per 17, FIG. 4. The grooves are depressed to a depth of about 25mils, although they could be depressed into the disc for a depth ofabout 40 mils.

The distance between each of the grooves 16, FIG. 2 is preferably about0.075 inches (75 mils) and the width of each groove 16 is about 0.075inches (75 mils). In connection with the invention, it is preferred thatthe width of the grooves 16 is equal to the width of the space betweeneach of the grooves 16, FIG. 2.

By reference to the drawings FIG. 3, it can be seen that the interiordisc 10 is comprised of an inner core 18 of a metal containing a highcarbon content and which is enclosed within an outer nickel layer 20.The outer nickel layer is substantially pure nickel.

In a slightly different embodiment of the invention, the metal elementsused in the formation of the disc would include the carbon and thenickel in the percentages as aforesaid. However, minor amounts of otherelements would also be in the composition and these include, forexample, phosphorus in an amount of 0.6% by weight, and silicon in anamount of 0.30% by weight. Manganese may be present in an amount ofabout 0.60% by weight. Vanadium, molybdenum and chromium may also bepresent in minor trace amounts. The phosphorus could actually range fromabout 0.4% to about 1.0%. The manganese could also range from about 0.1%to about 0.8%, and the silicon could also range from about 0.1% to about0.8%.

The aforesaid composition provides a disc of substantial hardness.However, it is not unduly brittle, and moreover, it is still flexibleproviding curvature and has a moderately light weight so that it can beworn comfortably and easily by a user

The invention can further be embodied such that the grooves 16constitute openings which extend between sides 12 and 14, 25 to 40 milsin length. FIG. 1, FIG. 4, FIG. 5 and FIG. 7 illustrate an embodiment inwhich the grooves are located on one flat surface of the disc, but donot extend all the way through from flat surface 17 to flat surface 19.

The interior disc of the Patch which is all natural and organic isadapted to be seated between cotton gauze on both sides and then 2 Telfapads as shown in FIG. 1.

The exterior housing of the disc consists of Telfa inner lined withcotton gauze, FIG. 1. Telfa is FDA approved under the classification ofvarious bandages and consists of a thin layer of absorbent cottonfibers, enclosed in a sleeve of polyethylene terephthalate, and bondedwith a thin layer of a perforated non-adherent film. This film does notadhere to the skin therefore, eliminating discomfort when removed. TheTelfa and cotton are inactive ingredients.

This milk suppression aid device was constructed by forming a piece ofhigh-carbon content metal into the shape illustrated in 10, FIG. 1 andFIG. 2. The disc has the overall dimension of 0.75 inch square, FIG. 2.The width of the spaces between each of the grooves 16 is 0.075 inchesand the width (horizontal dimension) of each of the individual groovesitself is 0.075 inches.

The overall device has a thickness of 343 mils or approximately ⅓ inch.The grooves 16 have a depth into the device of about 20 mils on each ofthe flat faces. The thickness of the inner core of high-carbon metal isabout 49.7 mils and the thickness of the outer layer of nickel is about0.3 mils.

Notably, the success of this invention resides in the wearing of thePatch between the woman's breasts. For optimal results women who willnot be breast-feeding should start wearing the breast patch withintwenty-four hours after child delivery. It should be worn continuouslyuntil engorgement pain and milk production cease. However, positiveresults are still achieved when started more than twenty-four hoursafter delivery.

One of the important aspects of this disc is that it does cause anyadverse effects. The use of the disc for the purpose of aiding thedrying of breast milk and relieving breast engorgement pain has beenexplored in conjunction with interaction with commonly used drugs. Theinteraction, if any, is set forth below:

DRUG INTERACTION  1. Ampicillin None known  2. Anticoagulants None known 3. Anticonvulsant hydantoin None known  4. Antidepressants tricyclic(TEA) None known  5. Anti-diabetic agents None known  6. AntihistaminesNone known  7. Barbiturates None known  8. Chloramphenicol None known 9. Clofibrate None known 10. .Dextrothyroxine None known 11.Guanethidine None known 12. Hypoglycemic (oral) None known 13. InsulinNone known 14. Meperidine None known 15. Meprobamate None known 16.Mineral oil None known 17. Non-steroidal anti-inflammatory drugs(NSAID's) None known 18. Rifampin None known 19. Sulfadiazine andPyrimethamine None known 20. Terazosin None known 21. Tetracyclic Noneknown 22. Urosodiol None known 23. Vitamin A None known 24. Vitamin ENone known 25. Anticoagulants (oral) None known 26. Anti-diabetic (oral)None known 27. Carbamazepine None known 28. Phenobarbital None known 29.Primidone None known 30. Tamoxifen None known 31. Thyriodhormones Noneknown 32. Bromocriptine None known 33. Hypoglycemic (oral) None known34. Oxyphenbutazone None known 35. Phenothiazines None known 36.Phenylbutazone None known

The use of the Holistic Breast Patch has also been explored for possibleinteraction with other substances. The interaction with severalsubstances, or lack thereof, is set forth below.

SUBSTANCE COMBINED EFFECT 1. Alcoholic beverages None Known 2.Nonalcoholic beverages None Known 3. Cocaine None Known 4. Foods/saltNone Known 5. Marijuana None Known 6. Tobacco/all forms None Known

EXAMPLES

The invention is further illustrated, but not limited to, the followingexamples:

Example 1

The Holistic Breast Patch aid device was used by a group of ten women.Each of the women was provided the device within twenty-four hours aftergiving birth. After wearing the device between the breasts for three tofive days each of the women reported that lactation was suppressed.

Example 2

The aid device was again used by a group of ten women. Each of the womenwas provided the device almost immediately after delivery. In each case,the birth was a normal delivery. After wearing the device between thebreasts for three to five days, engorgement of the breasts was reduced.

Thus, there has been illustrated and described a unique and novel deviceand method for aiding suppression of milk after pregnancy and relievingbreast engorgement pain which, therefore, fulfills all of the objectsand advantages which have been sought. It should be understood that manychanges, modifications, variations and other uses and applications willbecome apparent to those skilled in the art after considering thisspecification and the accompanying drawings.

Therefore, any and all such changes, modifications, variations and otheruses and applications which do not depart from the spirit and scope ofthe invention are deemed to be covered by the invention.

The claims of said device are inclusive of but not limited to thedescriptions and claims in the Specification.

Having thus described our invention, what we desire to claim and secureby application for Letters Patent are the following:
 1. A nonpharmaceutical lactation suppression device: safe, effective,comfortable, easy to use providing relief of pain and discomfortassociated with breast milk engorgement and therapeutic support andtreatment for prolactin dependent and prolactin related diseases andconditions
 2. A device as in claim 1 in which a metal disc is comprisedof an inner core of high-carbon content plus other elements includingnickel, manganese, phosphorus, silicon, sulfur, chromium, manganese,vanadium and molybdenum in varying combinations and amounts depending onthe embodiment. surrounded by an outer layer of relatively pure nickel3. A device as in claim 1 in which said device is encased in Telfa andgauze forming a patch